U.S. patent number 6,391,006 [Application Number 09/562,740] was granted by the patent office on 2002-05-21 for fluid delivery apparatus with reservoir fill assembly.
This patent grant is currently assigned to Science Incorporated. Invention is credited to Steven M. Arnold, James Garrison, Farhad Kazemzadeh, Marshall S Kriesel, Thomas N Thompson.
United States Patent |
6,391,006 |
Kriesel , et al. |
May 21, 2002 |
Fluid delivery apparatus with reservoir fill assembly
Abstract
An elastomeric bladder stored energy type infusion apparatus
that can be filled with a medicinal fluid and, after being filled,
can efficiently delivery the medicinal fluid to the patient at a
selected rate. The apparatus includes a delivery component for
delivering medicinal fluid to the patient and a fill component that
can expeditiously be used to fill the fluid reservoir of the
delivery component in the field.
Inventors: |
Kriesel; Marshall S (St. Paul,
MN), Arnold; Steven M. (Minnetanka, MN), Garrison;
James (Minneapolis, MN), Kazemzadeh; Farhad
(Bloomington, MN), Thompson; Thomas N (Richfield, MN) |
Assignee: |
Science Incorporated
(Bloomington, MN)
|
Family
ID: |
24247573 |
Appl.
No.: |
09/562,740 |
Filed: |
May 1, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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250036 |
Feb 12, 1999 |
6086561 |
|
|
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017047 |
Feb 2, 1998 |
5962794 |
|
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718686 |
Sep 24, 1996 |
5721382 |
|
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432220 |
May 1, 1995 |
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Current U.S.
Class: |
604/132; 604/153;
604/191 |
Current CPC
Class: |
A61M
5/152 (20130101); A61M 5/16854 (20130101); A61M
5/16886 (20130101); G01P 13/0026 (20130101); G01P
13/0066 (20130101); G01P 1/07 (20130101); A61M
2205/583 (20130101); A61M 2209/045 (20130101) |
Current International
Class: |
A61M
5/168 (20060101); A61M 5/145 (20060101); A61M
5/152 (20060101); G01P 13/00 (20060101); A61M
037/00 () |
Field of
Search: |
;604/85,86,82,131,132,133,151,153,156,185,191,184,890.1 |
Primary Examiner: Nguyen; Anhtuan T.
Attorney, Agent or Firm: Brunton, Esq.; James E.
Parent Case Text
BACKGROUND OF THE INVENTION
This is a Continuation-In-Part Application of application, Ser. No.
09/250,036 filed Feb. 12, 1999, now U.S. Pat. No. 6,086,561 which
is a Continuation-In-Part of Ser. No. 09/017,047 filed Feb. 2, 1998
which has now issued into U.S. Pat. No. 5,962,794, which is a
Continuation-In-Part of Ser. No. 08/718,686 filed Sep. 24, 1996,
now U.S. Pat. No. 5,721,382, which is a Continuation-In-Part of
application, Ser. No. 08/432,220, filed May 1, 1995, now abandoned.
Claims
We claim:
1. A device for use in infusing medicinal fluid into a patient at a
controlled rate comprising:
(a) a fluid dispenser including:
(i) a base having receiving chamber and an inlet port;
(ii) a stored energy means for forming, in conjunction with said
base, a fluid reservoir having an inlet in communication with said
chamber and an outlet, said stored energy means comprising at least
one distendable member superimposed over said base, said member
being distendable as a result of pressure imparted by the fluids to
be infused to establish internal stresses, said stresses tending to
move said member toward a less distended configuration;
(b) fill means interconnected with said receiving chamber of said
base for filling said reservoir, said fill means comprising:
(i) a container subassembly receivable within said receiving
chamber, said container subassembly including:
a. a container having a fluid chamber having first and second
ends;
b. displacement means movable relative to said fluid chamber for
dispensing fluid from said chamber; and
c. closure means for closing said second end of said fluid chamber
of said container and connector means for interconnecting said
fluid chamber of said container with a source of fluid.
(c) second fill means interconnected with said inlet port of said
base for filling said reservoir.
2. The delivery device as defined in claim 1 in which said
connector means includes a housing, a pierceable septum and a
closure panel hingedly connected to said housing for gaining access
to said pierceable septum.
3. The delivery device as defined in claim 1 in which said
connector means includes a luer connector connected to said
container.
4. The device as defined in claim 1 further including infusion
means connected to said base and being in fluid communication with
said fluid reservoir for infusing medicinal fluids into a
patient.
5. The device as defined in claim 1 in which said second fill means
comprises a container assembly including a container having a fluid
chamber and displacement means movable within said fluid chamber
and an adapter assembly comprising a hollow housing having an
outlet in communication with said inlet of said fluid reservoir and
also having a barrel portion receivable within said inlet port of
said base to connect said adapter assembly to said base, said
container being telescopically receivable in said housing.
6. The device as defined in claim 5, in which said adapter assembly
comprises pusher means for engagement with said displacement means
of said container assembly to move said displacement means within
said fluid chamber to urge fluid flow toward said fluid
reservoir.
7. The device as defined in claim 6 in which said pusher means
comprises a pusher member disposed within said hollow housing of
said adapter subassembly.
8. The device defined in claim 6 in which said adapter assembly
further comprises volume control means for controlling the volume
of fluid introduced into said reservoir.
9. The device as defined in claim 8 in which said hollow housing of
said adapter assembly is provided with an elongated track and in
which said volume control means comprises a stop member assembly
slidably movable relative to said track from a first position to a
second position.
10. The device as defined in claim 9 in which said hollow housing
of said adapter assembly is provided with volume indicating indicia
disposed proximate said elongated track.
11. The device as defined in claim 9 in which said stop member
assembly comprises a push button slidably receivable within said
track of said indicator housing.
12. The device as defined in claim 11 further including locking
means for locking said push button in position.
13. The device as defined in claim 11 in which said fluid dispenser
further includes fluid actuated indicator means for visually
indicating fluid flow from said fluid reservoir.
14. A device for use in infusing medicinal fluid into a patient at
a controlled rate comprising:
(a) a fluid dispenser including:
(i) a base having an inlet port;
(ii) a stored energy means for forming, in conjunction with said
base a fluid reservoir having an inlet in communication with said
inlet port and an outlet, said stored energy means comprising at
least one distendable member superimposed over said base, said
member being distendable as a result of pressure imparted by the
fluids to be infused to establish internal stresses, said stresses
tending to move said member toward a less distended configuration;
and
(iii) an outlet port in communication with said outlet of said
fluid reservoir for dispensing fluids from the device;
(b) an adapter fill assembly interconnectable with said inlet port
of said base for filling said fluid reservoir thereof, said adapter
fill assembly comprising:
(i) a container subassembly including a container having a fluid
chamber and displacement means movable within said fluid chamber;
and
(ii) an adapter assembly comprising:
a. a container-receiving housing having an elongated track, an
outlet in communication with said inlet of said fluid reservoir and
a barrel portion connected to said container receiving housing,
said barrel portion being receivable within said inlet port of said
base of said fluid dispenser to connect said adapter assembly to
said base, said container being telescopically receivable in said
container-receiving housing; and
b. volume control means for controlling the volume of fluid to be
introduced into said fluid reservoir, said volume control means
comprising a stop member slidably movable along said elongated
track of said container-receiving housing from a first position to
a second position, said stop member including a portion engageable
by said container of said container subassembly.
15. The device as defined in claim 14 in which said adapter
assembly further comprises locking means for locking said stop
member in position.
16. The device as defined in claim 14 in which said adapter
assembly further comprises operating means for moving said stop
member along said elongated track.
17. The device as defined in claim 14 in which said inlet port of
said base includes a pierceable septum and in which said adapter
assembly further comprises a cannula for piercing said pierceable
septum.
18. The device as defined in claim 14 in which said adapter fill
assembly further includes a second adapter assembly having a
container receiving housing for receiving a container.
19. The device as defined in claim 14 in which said base includes a
receiving chamber and in which said device further includes a fill
means receivable within said receiving chamber of said base for
filling said reservoir, said fill means comprising:
(a) a container subassembly receivable within said receiving
chamber, said container subassembly including:
(i) a container having a fluid chamber having first and second
ends;
(ii) displacement means movable relative to said fluid chamber for
dispensing fluid from said chamber; and
(iii) closure means for closing said second end of said fluid
chamber of said container, said closure means including a closure
subassembly connected to said second end of said container, said
closure subassembly comprising a housing, a closure panel hingedly
connected to said housing and connector means for interconnecting
said fluid chamber of said container with a source of fluid.
20. A device for use in infusing medicinal fluid into a patient at
a controlled rate comprising:
(a) a fluid dispenser including:
(i) a base having receiving chamber and an inlet port;
(ii) a stored energy means for forming, in conjunction with said
base a fluid reservoir having an inlet in communication with said
chamber and an outlet, said stored energy means comprising at least
one distendable member superimposed over said base, said member
being distendable as a result of pressure imparted by the fluids to
be infused to establish internal stresses, said stresses tending to
move said member toward a less distended configuration; and
(iii) an outlet port in communication with said outlet of said
fluid reservoir for dispensing fluids from the device;
(iv) fluid actuated indicator means for visually indicating fluid
flow from said reservoir; and
(b) an adapter fill means interconnectable with said inlet port of
said base for filling said fluid reservoir thereof, said adapter
fill means comprising:
(i) a container subassembly including a container having a fluid
chamber and displacement means movable within said fluid
chamber;
(ii) a first adapter assembly comprising:
a. a container-receiving housing having an elongated track, an
outlet in communication with said inlet of said fluid reservoir and
a barrel portion receivable within said inlet port of said base of
said fluid dispenser to connect said adapter assembly to said base,
said container being telescopically receivable within said housing;
and
b. volume control means for controlling the volume of fluid to be
introduced into said fluid reservoir of said fluid dispenser, said
volume control means comprising a stop member assembly movable
relative to said elongated tracks from a first position to a second
position, for engagement by said container of said container
subassembly; and
(iii) locking means for locking said stop member assembly in
position relative to said elongated track;
(c) a fill assembly receivable within said receiving chamber of
said base, said fill assembly including a container assembly
comprising:
(i) a container having a fluid chamber having first and second
ends;
(ii) displacement means movable relative to said fluid chamber for
dispensing fluid from said chamber; and
(iii) closure means for closing said second end of said fluid
chamber of said container, said closure means including a closure
subassembly connected to said second end of said container, said
closure subassembly comprising a housing.
21. The device as defined in claim 20 in which said closure means
comprises a closure panel hingedly connected to said housing and
connector means for interconnecting said fluid chamber of said
container with a source of fluid.
22. The device as defined in claim 20 further including a second
adapter assembly operably associated with said first adapter
assembly.
23. The device as defined in claim 20 in which said container
receiving housing of said first adapter assembly includes a
plurality of longitudinally spaced apart locking teeth, in which
said stop member assembly comprises a push button, and in which
said locking means comprises a pair of arms connected to said push
button; each of said arms having tabs engageable with said locking
teeth.
24. The device as defined in claim 23 in which said stop member
assembly comprises a stop member and in which said volume control
means comprises a threaded shaft connected to said stop member.
25. The device as defined in claim 23 in which said volume control
means further comprises operating means for imparting rotation to
said threaded shaft.
26. The device as defined in claim 24 further including locking
means for locking said threaded shaft against rotation.
Description
FIELD OF THE INVENTION
The present invention relates generally to fluid delivery devices.
More particularly, the invention concerns an improved apparatus,
including a fluid dispenser having visual flow indicator means, for
infusing medicinal agents into an ambulatory patient at specific
rates over extended periods of time and a novel reservoir fill
assembly for controllably filling the reservoir of the fluid
dispenser, including a fill assembly for filling the reservoir in
the field.
DISCUSSION OF THE INVENTION
Many medicinal agents require an intravenous route for
administration thus bypassing the digestive system and precluding
degradation by the catalytic enzymes in the digestive tract and the
liver. The use of more potent medications at elevated
concentrations has also increased the need for accuracy in
controlling the delivery of such drugs. The delivery device, while
not an active pharmacologic agent, may enhance the activity of the
drug by mediating its therapeutic effectiveness. Certain classes of
new pharmacologic agents possess a very narrow range of therapeutic
effectiveness, for instance, too small a dose results in no effect,
while too great a dose results in toxic reaction.
In the past, prolonged infusion of fluids has generally been
accomplished using gravity flow methods, which typically involve
the use of intravenous administration sets and the familiar bottle
suspended above the patient. Such methods are cumbersome, imprecise
and require bed confinement of the patient. Periodic monitoring of
the apparatus by the nurse or doctor is required to detect
malfunctions of the infusion apparatus.
Devices from which liquid is expelled from a relatively
thick-walled bladder by internal stresses within the distended
bladder are well known in the prior art. Such bladder, or "balloon"
type, devices are described in U.S. Pat. No. 3,469,578, issued to
Bierman and in U.S. Pat. No. 4,318,400, issued to Perry. The
devices of the aforementioned patents also disclose the use of
fluid flow restrictors external of the bladder for regulating the
rate of fluid flow from the bladder.
The prior art bladder type infusion devices are not without
drawbacks. Generally, because of the very nature of bladder or
"balloon" configuration, the devices are unwieldy and are difficult
and expensive to manufacture and use. Further, the devices are
somewhat unreliable and their fluid discharge rates are frequently
imprecise.
The apparatus of the present invention overcomes many of the
drawbacks of the prior art by eliminating the bladder and making
use of recently developed elastomeric films and similar materials,
which, in cooperation with a base define a fluid chamber that
contains the fluid which is to be dispensed. The elastomeric film
membrane controllably forces fluid within the chamber into fluid
flow channels provided in the base.
The elastomeric film materials used in the apparatus of the present
invention, as well as various alternate constructions of the
apparatus, are described in detail in U.S. Pat. No. 5,205,820
issued to one of the present inventors. Therefore, U.S. Pat. No.
5,205,820 is hereby incorporated by reference in its entirety as
though fully set forth herein. U.S. Pat. No. 5,721,382, also issued
to one of the present inventors, describes various alternate
constructions and modified physical embodiments of the invention,
including the provision of a novel fluid actuated indicator means
for visually indicating fluid flow from the device. This latter
U.S. Pat. No. 5,721,382 is also hereby incorporated by reference in
its entirety as though fully set forth herein.
Another somewhat similar apparatus to that of the present invention
is described in application Ser. No. 09/250,036 filed by the
present inventors on Feb. 12, 1999. Because of the pertinence of
this application, U.S. Ser. No. 09/250,036, now U.S. Pat. No.
6,086,561, is hereby incorporated by reference as through fully set
forth herein.
The apparatus of the present invention can be used with minimal
professional assistance in an alternate health care environment,
such as the home. By way of example, devices of the invention can
be comfortably and conveniently removably affixed to the patient's
clothing or to the patient's body and can be used for the
continuous infusion of antibiotics, hormones, steroids, blood
clotting agents, analgesics including morphine, and like medicinal
agents. Similarly, the devices can be used for I-V chemotherapy and
can accurately deliver fluids to the patient in precisely the
correct quantities and at extended microfusion rates over time.
One form of the apparatus of the present invention uniquely permits
the reservoir of the fluid-dispensing component to be filled in the
field.
Another form of the apparatus of the invention includes novel
volume control means for precisely controlling the volume of fluid
to be introduced into the reservoir of the dispensing
component.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an apparatus
for delivering fluids at a precisely controlled rate which
comprises a fluid dispensing component having a fluid reservoir for
containing the fluids to be delivered and a reservoir fill
component which can be removably interconnected with the fluid
dispensing component. More particularly, it is an object of the
invention to provide such an apparatus in which the reservoir fill
component can be used in the field to controllably fill the
reservoir of the dispensing component and in which the dispensing
component can be used for the precise infusion of pharmaceutical
fluids to an ambulatory patient at controlled rates.
It is another object of the invention to provide an apparatus of
the aforementioned character which is highly reliable and
easy-to-use by lay persons in a non-hospital environment.
A further object of the invention is to provide an accurate and
highly reliable fluid delivery device which can be manufactured
inexpensively in large volume by automated machinery.
Another object of the invention is to provide an apparatus of the
type described in the preceding paragraphs which includes novel
volume control means for precisely controlling the volume of
medicinal fluids that are introduced into the reservoir of the
fluid dispensing component.
Another object of the invention is to provide an apparatus of the
character described that includes first and second reservoir fill
assemblies for filling the fluid reservoir of the fluid dispensing
component.
Another object of the invention is to provide an apparatus of the
aforementioned character which includes a delivery component and a
filling component which can be operably interconnected with the
delivery component to enable expeditious filling in the field of
the reservoir of the delivery component. More particularly, the
first fill assembly permits the pharmacist to aseptically fill the
container under patient-specific-variable volume and concentration
of medicament. In this way, body mass index requirements can be met
for selected agents as, for example, immuno- and-chemo-therapeutic
agents.
Another object of the invention is to provide a device of the class
described in the preceding paragraphs in which the dispenser
component embodies a highly novel fluid flow indicator that
provides a readily discernible visual indication of fluid flow
status through the device.
Another object of the invention is to provide a device of the
aforementioned character in which the dispenser component includes
a novel infusion means in the form of delivery line assembly, which
can be interconnected with the dispenser.
Another object of the present invention is to provide a second
reservoir fill means in which the container of the fill means is
partially received within a novel adapter subassembly that can be
sealably connected to an outlet port provided in the base of the
fluid dispensing device.
Another object of the invention is to provide first and second
reservoir fill assemblies for use with the fluid dispenser
subassembly of the apparatus which are easy to use, are inexpensive
to manufacture, and which maintain the container of the fill
assemblies in a substantially aseptic condition until time of
use.
Other objects of the invention are set forth in U.S. Pat. Nos.
5,205,820 and 5,721,382 and 6,086,561 all of which are incorporated
herein by reference. Still further objects will become more
apparent from the discussion that follows.
By way of summary, the fluid delivery apparatus of the present form
of the invention comprises four cooperating components, namely a
fluid delivery apparatus or dispenser, an infusion means for
infusing medicaments into the patient and first and second
reservoir fill assemblies which can be coupled with the fluid
dispenser component for filling the fluid reservoir thereof. The
fluid dispenser, which readily lends itself to automated
manufacture, is generally similar to that described in U.S. Pat.
No. 5,721,382 and includes a base and a stored energy means
comprising at least one distendable elastomeric membrane which
cooperates with the base to form a fluid reservoir. The fluid
dispenser includes a highly novel fluid flow indicator means which
is substantially similar to that described in U.S. Pat. No.
6,086,561 and comprises a mechanical fluid flow indicator that
provides a clear visual indication of normal fluid flow and absence
of fluid flow from the fluid reservoir. One form of the reservoir
fill means of the invention also uniquely includes volume control
means for controlling the volume of fluid to be introduced into the
reservoir of the fluid dispenser by one of the fill means of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side-elevational, cross-sectional view of one form of
the apparatus of the invention, which includes a fluid delivery
component and first and second fill means for filling the reservoir
of the fluid delivery component.
FIG. 2 is a cross-sectional view taken along lines 2--2 of FIG.
1.
FIG. 3 is a fragmentary, top plan view of a portion of the delivery
component and of the first fill means of the invention.
FIG. 4 is a right-end view of the device shown in FIG. 3.
FIG. 5 is a fragmentary, side-elevational, cross-sectional view of
the base of the fluid delivery component of the invention.
FIG. 5A is a fragmentary, cross-sectional view of the pusher means
of the base component shown in FIG. 5, partly broken away to show
internal construction.
FIG. 5B is a right-end view of the pusher member shown in FIG.
5A.
FIG. 6 is an enlarged, side-elevational, cross-sectional view of
one form of the first fill means of the invention.
FIG. 6A is an exploded, cross sectional view of the first fill
means shown in FIG. 6.
FIG. 7 is a cross-sectional view similar to FIG. 6, but showing the
fluid chamber of the first fill means having been filled using a
syringe-type device.
FIG. 8 is a fragmentary, cross-sectional view of the right-end
portion of the first fill means shown in FIG. 6 illustrating the
manner of opening and closing the end panel of the device to enable
filling of the fill means in the field.
FIG. 9 is a fragmentary, cross-sectional view of an alternate form
of first fill means of the invention.
FIG. 9A is a fragmentary, cross-sectional, exploded view of the
first fill means shown in FIG. 9 illustrating the removal of the
end cap thereof to gain access to the fill port of the fill
means.
FIG. 9B is an exploded, cross-sectional view of a portion of the
first fill means shown in FIG. 9.
FIG. 10 is a fragmentary, cross-sectional view of still another
form of first fill means of the invention.
FIG. 11 is a fragmentary, cross-sectional view similar to FIG. 10,
but showing the removal of the end cap of the device to gain access
to a slit septum used to fill the fluid chamber of the device.
FIG. 12 is a generally perspective view of the form of the first
fill means shown in FIG. 6.
FIG. 13 is a generally perspective view of the alternate form of
first fill means of the invention shown in FIG. 9A.
FIG. 14 is a generally perspective, exploded view of the first fill
means shown in FIG. 10.
FIG. 15 is a generally perspective, exploded view of the fill means
shown in FIG. 13.
FIG. 16 is a generally perspective view of one form of the second
or adapter fill means of the invention.
FIG. 16A is a cross-sectional view of the adapter fill means shown
in FIG. 16.
FIG. 17 is a generally perspective, exploded view of one form of
the adapter fill assembly shown in FIG. 16.
FIG. 18 is a top plan view of the adapter fill assembly shown in
FIGS. 16 and 17.
FIG. 19 is a side elevational, cross-sectional view of the adapter
fill assembly shown in FIG. 18.
FIG. 20 is a cross-sectional view taken along lines 20--20 of FIG.
19.
FIG. 21 is an enlarged cross-sectional view of the area designated
in FIG. 20 by the numeral 21.
FIG. 22 is a top plan view of one form of the stop member of the
apparatus for controlling the extent of entry of the container
assembly into the adapter assembly.
FIG. 23 is a side-elevational view of the stop member shown in FIG.
22.
FIG. 24 is a generally perspective view of still another form of
adapter fill assembly of the invention.
FIG. 24A is a cross-sectional view taken along lines 24A--24A of
FIG. 24.
FIG. 25 is a top plan view of the fill assembly shown in FIG.
24.
FIG. 26 is a view taken along lines 26--26 of FIG. 25.
FIG. 27 is a cross-sectional view taken along lines 27--27 of FIG.
26.
FIG. 28 is an enlarged cross-sectional view taken along lines
28--28 of FIG. 26.
FIG. 29 is a cross-sectional view taken along lines 29--29 of FIG.
26.
FIG. 30 is a generally perspective top view of the indicator
housing of the fill assembly shown in FIG. 24.
FIG. 31 is a generally perspective bottom view of the indicator
housing shown in FIG. 30.
FIG. 32 is a generally perspective, exploded view of the adapter
fill assembly shown in FIG. 24.
FIG. 33 is an enlarged, fragmentary, cross-sectional view of the
control portion of the fill assembly for controlling the
positioning of the stop member of the container assembly.
FIG. 34 is a cross-sectional view similar to FIG. 33, but showing
the locking means of the assembly in a locked position locking the
stop member of the fill adapter in a fixed position.
FIG. 35 is a generally perspective view of still another form of
adapter fill assembly of the present invention.
FIG. 36 is a generally perspective, exploded view of the fill
assembly shown in FIG. 35.
FIG. 37 is a top plan view of the adapter fill assembly shown in
FIG. 35.
FIG. 38 is a view taken along lines 38--38 of FIG. 37.
FIG. 39 is a cross-sectional view taken along lines 39--39 of FIG.
38.
FIG. 40 is a cross-sectional view taken along lines 40--40 of FIG.
38.
FIG. 41 is an enlarged cross-sectional view taken along lines
41--41 of FIG. 38.
FIG. 42 is a generally perspective top view of the indicator
housing of the form of the invention shown in FIG. 35.
FIG. 43 is a generally perspective bottom view of the indicator
housing shown in FIG. 42.
FIG. 44 is a generally perspective view of one form of the locking
means of this latest form of the invention.
FIG. 45 is an enlarged, fragmentary, cross-sectional view of the
locking means portion of the fill adapter shown in FIG. 35.
FIG. 46 is a fragmentary, cross-sectional view similar to FIG. 45,
but showing the locking member in a locked position.
DESCRIPTION OF THE INVENTION
Referring to the drawings and particularly to FIGS. 1 through 5,
one form of the apparatus of the invention for controlled delivery
of medicinal fluid to a patient is there shown and generally
designated by the numeral 20. The apparatus here comprises four
major components, namely a fluid delivery component 22, first and
second fill assemblies 24 and 26 respectively and infusion means
for infusing medicinal fluids into the patient. The construction of
the first and second fill assemblies 24 and 26 will be described
hereinafter.
The fluid delivery component 22 includes a housing 30 having a base
assembly 32 and a stored energy means which cooperates with the
base assembly to form a fluid reservoir 34 (FIG. 1). Reservoir 34
is provided with first and second inlets 38 and 40 respectively.
Base assembly 32 also includes a base 42 having a receiving chamber
44 formed therein (FIG. 5). The stored energy means of this form of
the invention comprises an elastomeric membrane 46 which is clamped
to base 42 by means of a clamping ring 48 in a manner similar to
that described in incorporated by reference U.S. Pat. No.
5,840,071. Clamping ring 48, along with elastomeric membrane 46 is
enclosed by a cover 50 of the configuration shown in FIGS. 1 and 2.
As best seen in FIG. 1, receiving chamber 44 of base 42 is adapted
to controllably receive the first fill means or assembly 24 of the
invention to permit controlled filling of the reservoir of the
device via inlet 40. Base 42 also includes a fill port assembly 52
to which the second fill means or assembly 26 of the invention can
be removably interconnected. As indicated in FIG. 1, fill port
assembly 52 communicates with inlet 38 via a fluid passageway 39.
The construction and operation of the important fill port assembly
52 will presently be described.
Turning particularly to FIGS. 6, 6A, 7, 8 and 12, one form of the
first fill assembly 24 of the invention can be seen to comprise a
container subassembly 60 that includes a container, or vial portion
60a having a fluid chamber 62 for containing an injectable fluid
"F". As shown in FIG. 12, container subassembly 60 can be provided
with a medicament identification label 63. Fluid chamber 62 is
provided with first and second open ends 62a and 62b. First end 62a
is closed by an apertured, self-venting peel away aseptic cover 64.
Second open end 62b is sealably closed by closure means here
provided in the form of a closure subassembly 66. Displacement
means, here shown as a plunger 68 is telescopically movable within
chamber 62 of container subassembly 60 in the manner indicated in
FIGS. 6 and 7.
In the manner shown in FIGS. 6, 7, and 8 closure subassembly 66 is
sealably connected to container 60a and to a conically shaped
connector member 67, which has a fluid passageway 67a. Closure
assembly 66 comprises a generally cylindrically shaped closure
housing 70 and a closure panel 72 that is hingedly connected to
housing 70 by a living hinge 72a. Panel 72 is movable from the
closed position shown in FIG. 6 to the open position in FIG. 7.
Also comprising a part of closure subassembly 66 is connector means
for interconnecting fluid chamber 62 of container 60a with a source
of medicinal fluid. In the form of the invention shown in FIGS. 6
and 7 this connector means comprises a rearwardly extending male
luer connector 74. As shown in FIG. 6, when panel 72 is in the
closed position, a sealing protuberance 72b formed on end panel 72
will be sealably received within passageway 74a of connector 74 to
sealably close the passageway. When panel 72 is raised in the
manner shown in FIG. 7, connector 74 becomes accessible and can be
interconnected with a source of fluid such as a syringe S that
includes a female connector S-1. As chamber 62 is filled with
fluid, plunger 68 will be moved from the first position shown in
FIG. 6 to the second position shown in FIG. 7. Also forming a part
of closure subassembly 66 is valve means for controlling fluid flow
toward to chamber 62 of container 60a. In the present form of the
invention this valve means comprises a conventional umbrella check
valve 76.
Following filling of chamber 62 and removal of peel-away aseptic
cover 64, container subassembly 60 can be telescopically inserted
into receiving chamber 44 of base 42 and moved from a first
extended position shown in FIG. 1 into a second fluid filling
position. Disposed within chamber 44 is a pusher member 80 having
the configuration shown in FIGS. 5A and 5B. Pusher member 80
functions to move plunger 68 within the fluid chamber 62 of the
container subassembly as the container subassembly is inserted into
chamber 44. During the mating of the first fill means with the
fluid delivery component, the outer wall of vial 60a is closely
received within chamber 44 as the container subassembly is moved
inwardly or forwardly of the device housing. It is to be observed
that when the container subassembly is originally mated with the
delivery component in the manner shown in FIG. 1, threads 69
provided on plunger 68 will mate with internal threads 80a provided
on pusher member 80 (FIG. 5A) and a pierceable wall 68a of plunger
68 of container subassembly 60 will move into piercing engagement
with a hollow cannula 84 that is disposed centrally of pusher
member 80.
Once the fluid flow path between the hollow cannula 84 and the
fluid reservoir 34 of the delivery component 20 is thus created,
via a passageway 86 formed in base 42, via a second check valve 88
mounted within base 42 and a via inlet 40, the reservoir can be
filled as a result of an inward movement of the container
subassembly 60 into receiving chamber 44. As the container
subassembly moves inwardly, pusher member 80 will move plunger 68
rearwardly of chamber 62 causing the fluid contained therewithin to
be forced outwardly thereof through hollow cannula 84 and into
passageway 86. As the fluid enters inlet 40, elastomeric member 46
will be distended in the manner shown in FIG. 1 causing the buildup
of internal stresses within the member tending to return it to a
less distended position.
Referring next to FIGS. 9, 9A, 9B, 13 and 15, an alternative form
of first fill means of the invention is there illustrated. This
form of the invention is similar in many respects to that shown in
FIGS. 1 through 8 and previously described herein and like numerals
are used in FIGS. 9 and 9A to identify the like components shown in
FIGS. 6, 7 and 8. As illustrated in FIGS. 9 and 9A this alternate
form of first fill means of the invention also includes a container
60a having a fluid chamber 62. However, connected to container 60a
is an alternative form of closure subassembly that is generally
designated in FIGS. 9 and 9A by the numeral 89. Closure subassembly
89 is sealably connected to container 60a in the manner shown in
FIGS. 9 and 9A and includes an externally threaded closure housing
89a. Closure housing 89a comprises a luer connector member 91 which
is of the same general configuration as luer connector member 74.
Closure subassembly 89 further includes an end closure cap 89b
which is internally threaded so that it can be threadably
interconnected with housing 89a. During the filling step, access to
connector 91 is accomplished by threadably removing end cap 89b in
the manner shown in FIGS. 9A and 15 so as to enable the
interconnection therewith of a filling syringe, such as syringe S
(FIG. 7).
Turning to FIG. 10, still another form of first fill means of the
invention is there illustrated. This embodiment is similar in many
respects to those previously described, and like numerals are used
to identify like components. As before, this latest embodiment
includes a container 60a having a fluid chamber 62. Connected to
container 60a in the manner shown in FIG. 10 is a closure
subassembly 90. Subassembly 90 supports check valve 76 in a manner
shown in FIG. 10. As indicated in FIG. 10, in this latest form of
the first fill means, subassembly 90 includes a housing 92 and a
slit septum 94 which is sealably mounted within a collar 96 which
is, in turn, connected to housing 92. Slit septum 94 is accessible
by lifting hingedly mounted end panel 72 in the manner shown by the
phantom lines of FIG. 10 so that the septum can be pierced by the
cannula of a fill syringe of a character well known to those
skilled in the art to effect a controlled filling of chamber
62.
Referring next to FIG. 11, still another form of first fill means
of the invention is their illustrated. This form of the invention
is similar in many respects to that previously described and like
numerals are used in FIG. 11 to identify the like components shown
in FIGS. 10. As illustrated in FIG. 11, this alternate form of
first fill means also includes a container 60a having a fluid
chamber 62. Connected to container 60a is an alternative form of
closure subassembly generally designated as 104. Closure
subassembly 104 is connected to container 60a in the manner shown
in FIG. 11 and includes a closure housing 106. Connected to closure
housing 106 is an externally threaded septum housing 108 within
which a slit septum 110 is sealably mounted. Closure housing 106 is
connected to a connector member 67 which, in turn, is connected to
container 60a in the manner shown in FIG. 11. Adapted to threadably
mate with septum housing 108 is an end closure cap 112. End closure
cap 112 is internally threaded so that it can be threadably
interconnected with septum housing 108 in the manner indicated in
FIG. 11. During the filling step, access to septum 110 is
accomplished by threadably removing end cap 112 so as to enable
piercing of slit septum 110 by a cannula of a syringe or like
filling component.
Once the reservoir has been filled and the container subassembly
has been appropriately mated with delivery component 20, the
apparatus will remain in this readied condition until the
administration line 115 of the infusion means of the device is
opened. Once the administration line has been opened, the stored
energy means or membrane 46 will tend to return to a less distended
condition causing fluid to flow outwardly of the apparatus via
passageway 116, which is formed in base 42, via the novel indicator
means of the invention (FIG. 1). As previously mentioned, the
indicator means, which is generally identified in FIG. 1 by the
numeral 117, is of identical construction to that shown and
described in incorporated by reference application Ser. No.
09/250,036. Reference to this application should be made for a
description of the construction and operation of the indicator
means.
Considering next the second, or adapter fill assembly 26 of the
invention, this assembly is also used to fill reservoir 34 and
comprises a novel fluid transport assembly 120 of the general
configuration shown in FIGS. 1 and 16. Referring to FIGS. 16, 17,
18 and 19, it is to be noted that fluid transport assembly 120 is
specially designed to be mated with fill port assembly 52 formed in
base 42 of the fluid dispenser component 20. As best seen in FIGS.
16 and 16A, fluid transport assembly 120 comprises a fill assembly
26 which is substantially identical to that shown in FIG. 1 and
includes an adapter assembly 122 that telescopically accepts a
closed end container assembly 123.
Turning to FIGS. 16, 16A and 19, it is to be noted that threads
125a provided on a plunger 125 of container subassembly 123 of the
second fill assembly can be threadably connected to threads 126
provided on a pusher member 128 of adapter assembly 122. Pusher
member 128 also includes a cannula 130 which is constructed and
arranged to pierce the central wall 125b of plunger 125 when the
container subassembly 123 is mated with the adapter assembly 122.
Cannula 130 communicates with fluid chamber of the container 123a
of container subassembly 123 and here comprises a part of the
adapter flow control means of the adapter assembly for controlling
fluid flow toward reservoir 34.
As best seen in FIGS. 16, 16A and 19, adapter subassembly 122
comprises a hollow container receiving housing 132 having a first
open end 132a and a second closed end 132b. Container subassembly
123 of fill assembly 26 is telescopically receivable within open
end 132a of housing 132 so that container 123a thereof can be moved
from a first extended position shown in FIG. 16 to a second
advanced position wherein container 123a is at least partially
encapsulated within housing 132.
Also forming a part of the adapter assembly of the invention is a
connector means or cap assembly 134 (FIG. 19) which is connected to
body portion 132 in the manner shown in FIG. 19. Cap assembly 134
includes a generally cylindrical exterior wall 136, the interior
surface 136a of which forms a chamber 138 into which a cannula 140
extends. To interconnect second fill assembly 120 with the fluid
delivery apparatus, the barrel-like portion of closure cap 134 of
the second fill assembly is mated with fill port 52 formed in base
42. As the barrel-like portion enters the lower portion of the fill
port, the circumferentially spaced tabs 144 of closure cap 134 (see
FIGS. 16 and 19) are received within circumferentially spaced tab
receiving slots 146 formed in the fill port (FIG. 1). Cap 134 is
provided with an elastomeric O-ring 145 so that an inward pressure
exerted on the adapter assembly will effect a secure
interconnection and sterile coupling of the second fill assembly
with the fill port 52. As the second fill assembly 120 is mated
with the delivery component, cannula 140 of the fill assembly will
pierce a pierceable septum 148 which is mounted within fill port 52
in the manner shown in FIG. 1.
As best seen by referring to FIG. 17, container receiving housing
132 is provided with an elongated track 150. Connected to container
receiving housing 132 is an indicator housing 152 having an
elongated track 154 that is aligned with and overlays track 150 in
the manner shown in FIG. 20. Forming an important aspect of this
latest embodiment of the invention is volume control means for
controlling the volume of fluid to be introduced into fluid
reservoir 34 of the delivery component 20 by means of fill assembly
120. This volume control means comprises a stop means here provided
as a stop member assembly 155 which includes a push button 156 that
is slidably movable within elongated tracks 150 and 154 from a
first position to a second position. In a manner presently to be
described, push button 156 is constructed and arranged to be
engaged by container 123a of the fill assembly as the container is
introduced into container receiving housing 132 and, in this way,
functions to limit the extent of travel of the container within the
container receiving housing 132. By this mechanism, the volume of
fluid contained within container 123a that is to be introduced into
reservoir 34 of the fluid delivery component 20 can be precisely
controlled.
Referring particularly to FIGS. 17 through 23, it is to be noted
that push button 156 has an upper portion 156a, a lower portion
156b, and an intermediate portion 156c. Connected to intermediate
portion 156c is locking means for locking the stop means in
position. This locking means here comprises a longitudinally
extending connector member 160 (FIG. 22) to which a pair of
longitudinally extending arms 162 are connected. Arms 162 which
comprise the biasing means of this form of the invention, are
resiliently movable relative to connector member 160 so that
angularly shaped indexing tabs 166 that are provided proximate the
ends of arms 162 are continuously urged into engagement with a
plurality of longitudinally spaced apart locking teeth 168 that are
formed on the interior surface of indicator housing 152 (FIG.
19).
With the construction described in the preceding paragraph, the
stop member assembly 155 can be positioned longitudinally of
container receiving housing 132 by imparting a downward force on
push button 156 thus clearing tabs 166 from teeth 168 thereby
enabling the assembly to be moved forwardly or rearwardly of tracks
150 and 154 with tabs 166 slidably moving within a channel 153 (see
FIGS. 16A, 19 and 21). When the assembly is in the desired
position, a release of the downward pressure exerted on push button
156 will cause indexing tabs 166 to, once again, lockably engage
locking teeth 168 to lock assembly 155 in place. With the assembly
thusly locked in place by the locking means, the extent of entry of
container 123a will be positively controlled as will the volume of
fluid that will be introduced into reservoir 34. Provided on either
side of track 154 are indicating indicia 167 which indicate to the
user the volume of fluid that will be introduced into reservoir 34
at a particular setting of the stop assembly 155 within tracks 150
and 154.
With the stop assembly properly positioned, container 123a can be
moved into housing 132 until the container engages the lower
portion 156b of push button 156. As the container moves
telescopically inward of housing 132, fluid will flow from the
container into cannula 130, into central passageway 128a formed in
pusher member 128, into a stub passageway 132c and into cannula 140
via a conventional umbrella check valve 169 which is mounted within
cap 134 (FIG. 19) and via passageway 134a. Fluid will then flow
through cannula 140 into passageway 39 of base 42 and finally into
reservoir 34. As the fluid under pressure enters reservoir 34,
membrane 46 will be distended in the manner shown in FIG. 1.
Turning next to FIGS. 24 through 34, an alternate form of the
second, or adapter fill means of the invention is there shown and
generally designated by the numeral 170. This fill means, which is
also used to fill reservoir 34, is of a general configuration shown
in FIGS. 24, 25, and 26. Referring particularly to FIG. 24, it is
to be noted that fill means 170 is also specially designed to be
sealably mated with fill port assembly 52 of the fluid delivery
component 20. As illustrated in FIG. 24, fill means 170 comprises a
fill assembly 24 which is identical to that previously described
and an adapter assembly 174 which telescopically accepts container
subassembly 60 of fill assembly 24.
As before, threads 69 provided on plunger 68 of the container
subassembly 60 (FIG. 6) can be threadably connected to threads 176
provided on a pusher member 178 which comprises a part of adapter
assembly 174 (FIG. 26). Pusher member 178 also includes a cannula
180, that is constructed and arranged to pierce the central wall
68a of plunger 68 when the container subassembly 60 is mated with
the adapter assembly 174 (FIG. 6). Cannula 180 here comprises a
part of the adapter flow control means of the adapter assembly for
controlling fluid flow toward reservoir 34.
Referring particularly to FIGS. 25, 26, 27, and 28, it can be seen
that adapter subassembly 174 comprises a generally cylindrically
shaped hollow container receiving housing 182 having a first open
end 182a and a second closed end 182b. Container subassembly 60 of
the fill assembly is telescopically receivable within open end 182a
of housing 182 so that the container component 60a thereof can be
moved from a first extended position shown in FIG. 24 to a second
advanced position wherein container 60 is at least partially
encapsulated within housing 182.
Also forming a part of the adapter assembly of this latest form of
the invention is a connector means or cap assembly 184 (FIG. 24)
which is connected to body portion 182 in the manner shown in FIG.
26. Cap assembly 184 includes a generally cylindrical exterior wall
186, the interior surface 186a of which forms a chamber 188 into
which a cannula 190 extends. To interconnect fill means 170 with
the fluid delivery component 20, the barrel-like portion of closure
cap 184 of the fill means is sealably mated with fill port 52
formed in base 42. As the barrel-like portion enters the lower
portion of the fill port, the circumferentially spaced tabs 194 of
closure cap 184 (see FIGS. 24 and 26) are received within
circumferentially spaced tab receiving slots 146 formed in the fill
port (FIG. 1). As before, cap 184 is provided with an elastomeric
O-ring 195 so that an inward pressure exerted on the adapter
assembly will effect a secure interconnection and sterile coupling
of the fill means with the fill port 52. As the fill means 170 is
mated with the delivery component, cannula 190 of the fill assembly
will pierce the pierceable septum 148 which is mounted within fill
port 52.
As best seen by referring to FIGS. 25 through 32, container
receiving housing 182 includes an upper, curved portion 182c which
is provided with an elongated viewing window 197, the purpose of
which will presently be described. Connected to container receiving
housing 182 and forming a continuation of upper portion 182c is an
indicator housing 200 that houses a portion of the volume control
means of this latest form of the invention for controlling the
volume of fluid to be introduced into reservoir 34 (FIG. 24). This
volume control means here comprises an internally threaded stop
member 203 that is movable along a longitudinally extending track
201 that is formed within housing 182 (FIG. 28). As will be
described in greater detail hereinafter, stop member 203 is
controllably movable along track 201 by an elongated, externally
threaded operating shaft 202 that is journaled for rotation with
housing 182 and is rotated by operating means, which here comprises
a finger-engaging control knob 204.
As best seen by referring to FIGS. 28 and 32, shaft 202 includes an
enlarged diameter collar portion 202a that is provided with a
plurality of circumferentially spaced indexing grooves 205.
Received within grooves 205 is a spring tab 208 that extends
downwardly from indicator housing 200 in the manner shown in FIGS.
28 and 31. Spring tab 208 functions to index operating shaft 202
within indicator housing 200.
With the construction described in the preceding paragraph and as
illustrated in the drawings, rotation of control knob 204 will
cause rotation of shaft 202 which, in turn, will cause forward or
rearward movement of stop member 203 along track 201. As best seen
by referring to FIGS. 26, 27 and 32 lower, portion 203a of stop
member 203 extends downwardly into the interior of housing 182 so
that it will be engaged by container subassembly 60 as the
container subassembly is telescopically inserted into the open end
182a of hollow housing 182. Accordingly, the position of stop
member 203 within hollow housing 182 will control the extent of
travel of the container subassembly 60 within housing 182 and
thusly will control the amount of fluid contained within container
60a of container subassembly 60 that will be introduced into
reservoir 34 of the fluid delivery component 20. In this regard,
stop member 203 is provided with an indicating arrow 203b (FIG. 32)
which is visible through the viewing window 197 provided in housing
portion 182c. As shown in FIG. 25, volume-indicating indicia 211
are provided along viewing window 197. The position of indicating
arrow 203b relative to the volume-indicating indicia 211 indicates
the volume of fluid that will be introduced into the reservoir of
the fluid delivery component when the stop member 203 is moved to a
selected position along track 201.
An important feature of this latest embodiment of the invention
comprises locking means for locking stop member 203 in a selected
position within a hollow housing 182. This locking means here
comprises a locking pin 207 that is slidably carried within an
opening 209 formed within indicator housing 200 (FIGS. 30, 33 and
34). Locking pin 207 includes a hexagonal-shaped shaft 207a that
extends inwardly from a generally cylindrically shaped head portion
207b. Shaft 207a, which includes an enlarged diameter rib-like
portion 207c is received within opening 209 in the manner shown in
FIG. 33. When the locking means is in the first unlocked position
shown in FIG. 33, rib-like portion 207c is received within a
circumferentially extending groove 210 formed in opening 209.
However, when the locking means is moved into the second locking
position shown in FIG. 34, the inboard end of shaft 207a extends
inwardly of a generally hexagon-shaped opening 212 formed in
control knob 204 and rib-like portion 207c seats within a second
circumferentially extending groove 213 formed within opening 209.
As shown in FIG. 34, when the locking means is in the second locked
position and the inboard end of shaft portion 207a is received
within the opening 212, shaft 202 is securely locked against
rotation. Accordingly, as long as the locking means is in the
locked position shown in FIG. 34, the position of the locking
member 203 within the housing 182 cannot be changed and the volume
of fluid to be introduced into the reservoir of the fluid delivery
component will remain unchanged.
In using the apparatus of this latest form of the invention, when
the adapter fill means 170 is sealably interconnected with inlet
port 52 of the fluid delivery component 20 and the stop member of
the volume control means is appropriately set, an inward pressure
exerted on container subassembly 60 will cause fluid to flow from
fluid chamber 62 of the container into cannula 180, through a fluid
passageway 214, formed in pusher member 178 and into cannula 190
via umbrella check valve 169 which is carried within cap assembly
184 (FIG. 26). Fluid will then flow into reservoir 34 via inlet 38
(FIG. 1).
Turning next to FIGS. 35 through 46, still another form of the
second, or adapter fill means of the invention is there shown and
generally designated by the numeral 215. This fill means, which is
also used to fill reservoir 34, is similar in many respects to the
embodiment shown in FIGS. 24, 25, and 26 and like numerals are used
to identify like components. Referring particularly to FIG. 35, it
is to be noted that fill means 215 here comprises a pair of
interconnected, back-to-back fill assemblies 217, each of which is
comparable in construction to the earlier described adapter fill
means 170. As before, fill means 215 is specially designed to be
sealably mated with fill port assembly 52 of the fluid delivery
component 20. As illustrated in FIG. 35, each of the back-to-back
fill assemblies 217 include a fill assembly 24 which is identical
to that previously described and an adapter assembly 174 which is
substantially identical to that previously described and
telescopically accepts the container subassembly 60 of the fill
assembly 24.
As before, threads 69 provided on plunger 68 of the container
subassembly 60 (FIG. 16A) can be threadably connected to threads
176 provided on pusher member 178 of each of the adapter assemblies
174 (see FIG. 36). Pusher member 178 also includes a cannula 180
which is constructed and arranged to pierce the central wall 68a of
plunger 68 when the container subassembly 60 is mated with the
adapter assembly 174 in the manner previously described. As before,
cannula 180 comprises a part of the adapter flow control means of
the adapter assembly for controlling fluid flow toward reservoir
34.
Referring particularly to FIGS. 36 and 38, it can be seen that each
of the back-to-back adapter subassemblies 174 is of the general
construction previously described in connection with the embodiment
of FIGS. 24 through 34 save for a common integral housing and each
comprises a generally cylindrically shaped hollow container
receiving housing 182 having a first open end 182a and a second
closed end 182b. Container subassembly 60 is telescopically
receivable within open end 182a of housing 182 so that the
container 60a thereof can be moved from a first extended position
shown in FIGS. 24A and 35 to a second, advanced position wherein
container 60a is at least partially encapsulated within housing
182.
Also forming a part of the adapter fill means of this latest form
of the invention is a connector means or cap assembly 184 (FIG. 35)
which is connected to end portions 182b of housing 182 in the
manner shown in FIG. 38. As before, cap assembly 184 includes a
generally cylindrical exterior wall 186, the interior surface of
which forms a chamber 188 into which a cannula 190 extends (FIG.
38). To interconnect fill means 215 with the fluid delivery
component, the barrel-like portion of closure cap 184 is sealably
mated with fill port 52 formed in base 42. As the barrel-like
portion enters the lower portion of the fill port, the
circumferentially spaced tabs 194 of closure cap 184 (see FIGS. 35
and 38) are received within circumferentially spaced tab receiving
slots 146 formed in the fill port (FIG. 1). As before, cap 184 is
provided with an elastomeric O-ring 195 so that an inward pressure
exerted on the adapter assembly will effect a secure
interconnection and sterile coupling of the fill means with the
fill port 52. As the fill means 215 is mated with the delivery
component, cannula 190 of closure cap 184 will pierce a pierceable
septum 148 which is mounted within fill port 52. Provided between
cannula 190 and each of the container subassemblies 60 are flow
control means, shown here as a pair of check valves 193 which,
along with check valve 169, control fluid flow toward cannula 190.
The chambers that house check valves 193 communicate with the
chamber that houses check valve 169 via flow passageways 182d.
Similarly the chamber that houses check valve 169 communicates with
cannula 190 via a passageway 169a.
As best seen by referring to FIGS. 36 through 40, each container
receiving housing 182 includes an upper, curved portion and 182c
which is provided with an elongated viewing window 197. Connected
to each container receiving housing 182 and forming a continuation
of upper portion 182c thereof is an indicator housing 200 that
houses a portion of the volume control means of this latest form of
the invention for controlling the volume of fluid to be introduced
into reservoir 34. This volume control means is identical to that
previously described and operates in an identical manner.
As in the earlier described embodiment, the position of stop member
203 of the volume control means within each of the hollow housings
182 will control the extent of travel of the container subassembly
60 of the fill means 24 into that housing and thusly will control
the amount of fluid contained within the particular container
subassembly 60 that will be introduced into reservoir 34 of the
fluid delivery component 20.
This latest embodiment, like the earlier described embodiment, also
comprises locking means for locking the stop members 203 in a
selected position within each of the hollow housings 182. This
locking means is also identical in construction and operation to
that described in connection with the previously discussed
embodiment of the invention. As before, when the locking means of a
selected one of the adapter subassemblies 174 is moved into the
second, locking position shown in FIG. 46, shaft portion 207a of
that locking means extends into a generally hexagon-shaped opening
212 formed in the outboard end of shaft 202 of that locking means
and rib-like portion 207c seats within second circumferentially
extending grooves 213 that are formed within opening 209 of the
adapter subassembly. When the locking means is in the second locked
position and shaft portion 207a is received within the opening 212,
shaft 202 is securely locked against further rotation by rotation
of the control knob 204. Accordingly, as long as the locking means
is in the locked position shown in FIG. 46, the position of the
locking member 203 within the selected housing 182 cannot be
changed and the volume of fluid to be introduced into the reservoir
of the fluid delivery component from the container of that
subassembly will remain unchanged.
With the novel construction of this latest, dual-container
subassembly embodiment, selected fluids in selected, controlled
volumes can be separately or simultaneously introduced into the
fluid reservoir of the fluid delivery component.
Having now described the invention in detail in accordance with the
requirements of the patent statutes, those skilled in this art will
have no difficulty in making changes and modifications in the
individual parts or their relative assembly in order to meet
specific requirements or conditions. Such changes and modifications
may be made without departing from the scope and spirit of the
invention, as set forth in the following claims.
* * * * *